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Medical Device Testing Specialist
2 months ago
We are seeking a highly skilled Stability Scientist I to join our team at ConvaTec, a global leader in medical products and technologies. As a key member of our Quality Assurance team, you will play a critical role in ensuring the safety and efficacy of our medical devices.
Key Responsibilities- Design, plan, and execute physical testing in support of R&D and SEG activities, adhering to applicable procedures and guidelines.
- Develop and validate new physical testing methods to enhance our product development process.
- Organize and prioritize assigned workload, ensuring the integrity of all data generated and timely provision of results to GLP standards.
- Analyze laboratory data accurately and author concise investigation reports to identify root causes of atypical and out-of-specification results.
- Author validation protocols, reports, and technical documents for Medical Devices/Pharmaceutical products.
- Assist in laboratory test method/procedural revisions and ensure lab compliance with applicable cGMP regulations and SOPs/TDs.
- Participate in change control activities and associated actions.
- Bachelor's Degree in a relevant science-related discipline.
- Experience in a working laboratory environment, within Medical Devices/Pharmaceutical Industry is preferred.
- Working knowledge and understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulations.
- Good working knowledge of Microsoft Office, specifically Word and Excel.
- A detailed understanding of common statistical analysis and experience with MiniTab is desirable.
- Have an understanding of the role of Physical Testing within the product development process for both new product development and existing product development of medical devices/pharmaceuticals.
- Commands good physical testing and problem-solving skills and demonstrates an understanding of the steps involved in initiating and completing a variety of physical testing tasks to support key R&D projects.
- Statically analyze data for reporting to senior physical testing staff.
- Effectively communicate both oral and written scientific and technical data to peers and managers.
- A thorough knowledge and understanding of the principles and concepts of compliance management, GMP/GLP and good documentation practices.
- Competent in the production of high-quality, accurate R&D technical documentation in a timely manner.
- A forward-thinking team-player who willingly accepts new challenges and works to tight deadlines.
- Commands Flexibility - ability to prioritize, manage multiple tasks and react/respond positively to changes in priority and workload.
- Accurate with excellent attention to detail.
- Decisive thinker: ability to make decisions and recommendations using own initiative.
